Multiple Myeloma
Conditions
Brief summary
The purpose of this study was to determine the safety and tolerability of dasatinib when given in combination with lenalidomide and a low dose dexamethasone for the treatment of relapsed or refractory multiple myeloma.
Interventions
DRUGDasatinib, 70 mg + Lenalidomide, 15 mg + Dexamethasone, 40 mg
Participants received dasatinib, 70 mg once daily (QD), for 28 days plus lenalidomide, 15 mg QD, for 21 days plus dexamethasone, 40 mg QD, weekly on Days 1, 8, 15, and 22.
DRUGDasatinib, 70 mg + Lenalidomide, 20 mg + Dexamethasone, 40 mg
Participants received dasatinib, 70 mg QD, for 28 days plus lenalidomide, 20 mg QD, for 21 days, plus dexamethasone, 40 mg QD, weekly on Days 1, 8, 15, and 22.
DRUGDasatinib, 100 mg + Lenalidomide, 20 mg + Dexamethasone, 40 mg
Participants received dasatinib, 100 mg QD, for 28 days, plus lenalidomide, 20 mg QD, for 21 days, plus dexamethasone, 40 mg QD, weekly on Days 1, 8, 15, and 22.
DRUGDasatinib, 100 mg + Lenalidomide, 25 mg + Dexamethasone, 40 mg
Participants received dasatinib, 100 mg QD, for 28 days, plus lenalidomide, 25 mg QD, for 21 days, plus dexamethasone, 40 mg QD, weekly on Days 1, 8, 15, and 22.
DRUGDasatinib, 140 mg + Lenalidomide, 25 mg + Dexamethasone, 40 mg
Participants received dasatinib, 140 mg QD, for 28 days, plus lenalidomide, 25 mg QD, for 21 days, plus dexamethasone, 40 mg QD, weekly on Days 1, 8, 15, and 22. Cohort includes 4 participants who received treatment during the dose-finding phase and 13 participants who received treatment in the dose-expansion phase.
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Able to provide written informed consent * Men and women age ≥ 18 years * Confirmed diagnosis of multiple myeloma (MM) with measurable disease assessed within 1 month prior to treatment initiation * Evidence of relapsed or refractory disease and at least one prior therapy for MM * Eastern Cooperative Oncology Group Scale (ECOG) Performance Status of 0 - 2 * Last MM treatment at least 21 days prior to treatment initiation• Bone marrow transplant (BMT) at least 3 months prior to treatment initiation * Required baseline hematology and chemistry parameters * Resolution of acute toxicity due to prior therapy to Grade \<2 per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0
Exclusion criteria
* Women who are pregnant or breastfeeding * Men whose sexual partners are women of child bearing potential (WOCBP) or WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least one month (4 weeks) before and for at least one month (4 weeks) after the last dose of study medication. * Clinically significant cardiac disease (New York Heart Association \[NYHA\] Class III or IV) * Abnormal corrected QT interval using Fridericia's formula (QTcF) interval prolonged (\> 450 msec) * Medications that are generally considered to have a risk of causing Torsades de Pointes * Malabsorption syndrome or uncontrolled gastrointestinal toxicities * Clinically significant pleural effusion in the previous 12 months or current ascites * Clinically-significant coagulation or platelet function disorder * Dementia, chronic medical or psychiatric condition, or laboratory abnormality * Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality, serious uncontrolled medical disorder or active infection * Intolerance to dasatinib and/or lenalidomide * Subjects with a history of severe rash, hypersensitivity reaction or anaphylaxis related to prior thalidomide treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Baseline (pretreatment); Cycles 1 and 2 (within 24 hours of Days 1, 4, 8, 11, 15, 18, 21, and 25); beyond Cycle 2 (within 24 hours of Days 1 and 15,off treatment visit ) (median duration of dasatinib treatment=5.2 mo [range 0 to 33 mo]) | Grading as per NCI CTCAE Version 3.0 criteria. GR1=Mild; GR2=Moderate; GR3=Severe; GR4=Life-threatening or disabling. Calcium (low): GR1: \<LLN - 8.0 mg/dL, GR2: \<8.0 - 7.0 mg/dL, GR3: \<7.0 - 6.0 mg/dL, GR4: \<6.0 mg/dL. Calcium (High): GR1: \>ULN - 11.5 mg/dL, GR2: \>11.5 - 12.5 mg/dL, GR3: \>12.5 - 13.5 mg/dL, GR4: \>13.5 mg/dL. Magnesium (Low): GR1: \<LLN - 1.2 mg/dL, GR2: \<1.2 - 0.9 mg/dL, GR3: \<0.9 - 0.7 mg/dL, GR4: \<0.7 mg/dL. Phosphorus (low): GR1: \<LLN - 2.5 mg/dL, GR2: \<2.5 - 2.0 mg/dL, GR3: \<2.0 - 1.0 mg/dL, GR4: \<1.0 mg/dL. BL=Baseline; PBL=post baseline. |
| Number of Participants Who Died, Serious Adverse Events (SAEs), Adverse Events (AEs) and AEs Leading to Study Drug Discontinuation | Baseline (pretreatment), from the date of first dose until at least 30 days after the last dose of study drug (median duration of dasatinib treatment=5.2 months [range 0 to 33 months]). | AE: New untoward medical occurrence or worsening of a preexisting medical condition that does not have causal relationship with this treatment. SAE: Untoward medical event that at any dose: results in death, persistent or significant disability/incapacity, drug dependency/abuse; life-threatening, an important medical event, a congenital anomaly/birth defect; requires inpatient hospitalization/prolongs existing hospitalization. Grade 1= Mild; Grade 2= Moderate; Grade 3= Severe; Grade 4 = Life-threatening or disabling. |
| Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Baseline (pretreatment); Cycles 1 and 2 (within 24 hours of Days 1, 4, 8, 11, 15, 18, 21, and 25); beyond Cycle 2 (within 24 hours of Days 1 and 15,off treatment visit ) (median duration of dasatinib treatment=5.2 mo [range 0 to 33 mo]) | As per NCI CTCAE Version 3.0 criteria. Grade (GR)1=Mild; GR2=Moderate; GR3=Severe; GR4=Life-threatening or disabling. White blood cell (WBC):GR1=\<LLN(lower limit of normal)-3.0\*10\^9/L; GR2=\<3.0-2.0\*10\^9/L; GR3:\<2.0-1.0\*10\^9/L; GR4:\<1.0\*10\^9/L. LLN=lower limit of normal. Absolute Neutrophil Count (ANC): GR1=\<LLN-1.5\*10\^9/L; GR2=\<1.5-1.0\*10\^9/L; GR3:\<1.0-0.5\*10\^9/L; GR4:\<0.5\*10\^9/L. Hemoglobin: GR1=\<LLN-10.0g/dL; GR2=\<10.0-8.0g/dL; GR3:\<8.0-6.5g/dL; GR4:\<6.5g/dL. Platelets: GR1=\<LLN-75.0\*10\^9/L; GR2=\<75.0-50.0\*10\^9/L; GR3:\<50.0-25.0\*10\^9/L; GR4:\<25.0\*10\^9/L. BL=Baseline; PBL=post baseline. |
| Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC) | Baseline (pretreatment); Cycles 1 and 2 (within 24 hours of Days 1, 4, 8, 11, 15, 18, 21, and 25); beyond Cycle 2 (within 24 hours of Days 1 and 15,off treatment visit ) (median duration of dasatinib treatment=5.2 mo [range 0 to 33 mo]) | Grading as per NCI CTCAE Version 3.0 criteria. GR1=Mild; GR2=Moderate; GR3=Severe; GR4=Life-threatening or disabling. Aspartate aminotransferase (AST) and alanine aminotransferase(ALT): GR1=\>ULN-2.5\*ULN (upper limit of normal); GR2=\>2.5-5.0\*ULN; GR3=\>5.0-20.0\*ULN; GR4:\>20.0\*ULN; TB:GR1=\>ULN-1.5\*ULN, GR2=\>1.5-3.0\*ULN, GR3=\>3-10\*ULN, GR4=\>10\*ULN; SC: GR1=\>ULN-1.5\*ULN, GR2=\>1.5-3.0\*ULN, GR3=\>3.0-6.0\*ULN, GR4=\>6.0\*ULN. BL=Baseline; PBL=post baseline. |
| Recommended Phase II Dose (RP2D) of the Combination (Dasatinib + Lenalidomide + Dexamethasone) | From the date of first dose to end of treatment (median duration of dasatinib treatment=5.2 months [range 0 to 33 months]). | The RP2D was based on the MTD which was defined as the maximum combined dose producing dose limiting toxicity (DLT) in \< 33% of participants treated at the individual dose levels in the combination. The MTD is considered the last dose level combination tested just below the maximum administered dose (MAD) level combination and for which DLTs were observed in less than or equal to 33% of participants during the escalation and expansion phase. If MTD was not reached Please refer to Outcome Measure 2 for the complete definition of DLT. |
| Number of Participants With Dose-limiting Toxicity (DLT) | From the date of first dose until at least 30 days after the last dose of study drug (median duration of dasatinib treatment=5.2 months [range 0 to 33 months]). | DLTs: At least possibly drug-related AEs occurring during the first cycle of treatment and are:GR4 neutropenia \>5 days/neutropenic fever;platelet count \<10000mm\^3 on \>1 occasion;GR4 fatigue,or 2-point decline in ECOG performance status;\>=GR3 nausea,diarrhea,and vomiting despite medical intervention;Any other clinically significant non-hematologic toxicity of \>=GR3 considered not related to underlying MM;Any GR3/4 laboratory abnormality requiring hospitalization;dose interruption of either dasatinib and/or lenalidomide for \>15 days due to any toxicity related to treatment with the combination. |
| Number of Participants in the Dose Escalation Phase Who Reached Maximum Tolerated Dose (MTD) of Dasatinib With Lenalidomide and Dexamethasone | From the date of first dose to end of treatment (median duration of dasatinib treatment=5.2 months [range 0 to 33 months]). | The MTD is considered the last dose level combination tested just below the maximum administered dose (MAD) level combination and for which DLTs were observed in less than 33% of participants during the escalation and expansion phase. Please refer to outcome 2 for the complete definition of DLT. If the MTD was not reached at the highest dose administered as defined by protocol, the highest dose (dasatinib 140 mg QD + lenalidomide 25 mg QD) administered was selected for the dose expansion phase of the study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Partial Response | Baseline, at the end of the treatment period (median duration of dasatinib treatment=5.2 months [range 0 to 33 months]). | Partial response was achieved when there was ≥50% reduction of serum M-protein (Mpr)and reduction in 24 hour urinary Mpr by ≥90% or to \<200 mg/24 hr. If the serum and urine Mpr were unmeasurable, a ≥50% decrease in the difference between involved and uninvolved free light chain (FLC) levels was required in place of the Mpr criteria. If serum, urine Mpr, and serum FLC assay were unmeasurable, ≥50% reduction in plasma cells was required in place of Mpr, provided baseline bone marrow plasma cell percentage was ≥30%; a ≥50% reduction in the size of soft tissue plasmacytomas was also required. |
| Number of Participants With Minimal Response | Baseline, at the end of the treatment period (median duration of dasatinib treatment=5.2 months [range 0 to 33 months]). | Response criteria was based on The International Uniform Response Criteria for Multiple Myeloma (with a slight modification). Minimal Response was achieved when there was 25% to 49% reduction of serum M-Protein, 50% to 89% reduction in 24 hour urinary M-protein which still exceeded 200 mg/24 hour. If the serum and urine M-protein were unmeasurable, 25% to 49% reduction in plasma cells was required. In addition, if present at baseline, a 25% to 49% reduction in the size of soft tissue plasmacytomas was also required. |
| Number of Participants With Complete Response and Very Good Partial Response | Baseline, At the end of the treatment period (median duration of dasatinib treatment=5.2 months [range 0 to 33 months]). | Response criteria were based on The International Uniform Response Criteria for Multiple Myeloma (with a slight modification). Complete response was achieved when there was negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow. Very good partial response was achieved when serum and urine M-component was detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-component plus urine M-component \< 100 mg per 24 hour. |
Countries
Australia, France, United States
Participant flow
Pre-assignment details
Of 39 participants were enrolled in this study, 4 never received treatment due to screening failure. A total of 35 participants received treatment.
Participants by arm
| Arm | Count |
|---|---|
| Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 15 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). | 6 |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). | 3 |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). | 3 |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). | 6 |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 140 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). Cohort includes 4 participants treated for dose -finding phase and 13 participants treated in dose expansion phase. | 17 |
| Total | 35 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Still on treatment | 0 | 0 | 0 | 1 | 2 |
Baseline characteristics
| Characteristic | Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg | Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 69.3 years STANDARD_DEVIATION 4.73 | 63.0 years STANDARD_DEVIATION 11.14 | 69.7 years STANDARD_DEVIATION 5.92 | 66.2 years STANDARD_DEVIATION 11.75 | 59.3 years STANDARD_DEVIATION 8.06 | 63.4 years STANDARD_DEVIATION 9.19 |
| Age, Customized 21 - 45 years | 0 participants | 0 participants | 0 participants | 0 participants | 1 participants | 1 participants |
| Age, Customized 46 - 65 years | 1 participants | 2 participants | 1 participants | 3 participants | 13 participants | 20 participants |
| Age, Customized 66 - 75 years | 2 participants | 1 participants | 5 participants | 1 participants | 3 participants | 12 participants |
| Age, Customized >75 years | 0 participants | 0 participants | 0 participants | 2 participants | 0 participants | 2 participants |
| Durie-Salmon Staging System Not Assessed | 0 participants | 0 participants | 2 participants | 0 participants | 6 participants | 8 participants |
| Durie-Salmon Staging System Stage IA | 1 participants | 2 participants | 1 participants | 3 participants | 2 participants | 9 participants |
| Durie-Salmon Staging System Stage IB | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants |
| Durie-Salmon Staging System Stage IIA | 0 participants | 1 participants | 3 participants | 0 participants | 3 participants | 7 participants |
| Durie-Salmon Staging System Stage IIB | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants |
| Durie-Salmon Staging System Stage IIIA | 2 participants | 0 participants | 0 participants | 3 participants | 6 participants | 11 participants |
| Durie-Salmon Staging System Stage IIIB | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants |
| International Staging System (ISS) Not assessed | 1 participants | 2 participants | 2 participants | 3 participants | 10 participants | 18 participants |
| International Staging System (ISS) Stage I | 0 participants | 1 participants | 0 participants | 1 participants | 4 participants | 6 participants |
| International Staging System (ISS) Stage II | 0 participants | 0 participants | 3 participants | 1 participants | 2 participants | 6 participants |
| International Staging System (ISS) Stage III | 2 participants | 0 participants | 1 participants | 1 participants | 1 participants | 5 participants |
| Race/Ethnicity, Customized Asian | 0 participants | 0 participants | 0 participants | 0 participants | 1 participants | 1 participants |
| Race/Ethnicity, Customized White | 3 participants | 3 participants | 6 participants | 6 participants | 16 participants | 34 participants |
| Sex: Female, Male Female | 2 Participants | 1 Participants | 4 Participants | 4 Participants | 7 Participants | 18 Participants |
| Sex: Female, Male Male | 1 Participants | 2 Participants | 2 Participants | 2 Participants | 10 Participants | 17 Participants |
| Time from diagnosis to first dosing | 4.0 years | 7.5 years | 5.2 years | 4.9 years | 3.7 years | 4.4 years |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 3 / 3 | 6 / 6 | 17 / 17 | 0 / 6 | 0 / 3 |
| serious Total, serious adverse events | 2 / 3 | 5 / 6 | 9 / 17 | 0 / 6 | 0 / 3 |
Outcome results
Primary
Number of Participants in the Dose Escalation Phase Who Reached Maximum Tolerated Dose (MTD) of Dasatinib With Lenalidomide and Dexamethasone
The MTD is considered the last dose level combination tested just below the maximum administered dose (MAD) level combination and for which DLTs were observed in less than 33% of participants during the escalation and expansion phase. Please refer to outcome 2 for the complete definition of DLT. If the MTD was not reached at the highest dose administered as defined by protocol, the highest dose (dasatinib 140 mg QD + lenalidomide 25 mg QD) administered was selected for the dose expansion phase of the study.
Time frame: From the date of first dose to end of treatment (median duration of dasatinib treatment=5.2 months [range 0 to 33 months]).
Population: All treated participants, participants who received at least 1 dose of dasatinib. (Participants included from Cohort 5 are those involved in the dose escalation phase only.)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Treated Participants | Number of Participants in the Dose Escalation Phase Who Reached Maximum Tolerated Dose (MTD) of Dasatinib With Lenalidomide and Dexamethasone | 0 participants |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants in the Dose Escalation Phase Who Reached Maximum Tolerated Dose (MTD) of Dasatinib With Lenalidomide and Dexamethasone | 0 participants |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants in the Dose Escalation Phase Who Reached Maximum Tolerated Dose (MTD) of Dasatinib With Lenalidomide and Dexamethasone | 0 participants |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants in the Dose Escalation Phase Who Reached Maximum Tolerated Dose (MTD) of Dasatinib With Lenalidomide and Dexamethasone | 0 participants |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants in the Dose Escalation Phase Who Reached Maximum Tolerated Dose (MTD) of Dasatinib With Lenalidomide and Dexamethasone | 0 participants |
Primary
Number of Participants Who Died, Serious Adverse Events (SAEs), Adverse Events (AEs) and AEs Leading to Study Drug Discontinuation
AE: New untoward medical occurrence or worsening of a preexisting medical condition that does not have causal relationship with this treatment. SAE: Untoward medical event that at any dose: results in death, persistent or significant disability/incapacity, drug dependency/abuse; life-threatening, an important medical event, a congenital anomaly/birth defect; requires inpatient hospitalization/prolongs existing hospitalization. Grade 1= Mild; Grade 2= Moderate; Grade 3= Severe; Grade 4 = Life-threatening or disabling.
Time frame: Baseline (pretreatment), from the date of first dose until at least 30 days after the last dose of study drug (median duration of dasatinib treatment=5.2 months [range 0 to 33 months]).
Population: All treated participants, participants who received at least 1 dose of dasatinib.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Treated Participants | Number of Participants Who Died, Serious Adverse Events (SAEs), Adverse Events (AEs) and AEs Leading to Study Drug Discontinuation | Drug-related AEs | 6 participants |
| All Treated Participants | Number of Participants Who Died, Serious Adverse Events (SAEs), Adverse Events (AEs) and AEs Leading to Study Drug Discontinuation | All SAEs | 3 participants |
| All Treated Participants | Number of Participants Who Died, Serious Adverse Events (SAEs), Adverse Events (AEs) and AEs Leading to Study Drug Discontinuation | Drug-related SAEs | 1 participants |
| All Treated Participants | Number of Participants Who Died, Serious Adverse Events (SAEs), Adverse Events (AEs) and AEs Leading to Study Drug Discontinuation | All deaths | 3 participants |
| All Treated Participants | Number of Participants Who Died, Serious Adverse Events (SAEs), Adverse Events (AEs) and AEs Leading to Study Drug Discontinuation | All AEs | 6 participants |
| All Treated Participants | Number of Participants Who Died, Serious Adverse Events (SAEs), Adverse Events (AEs) and AEs Leading to Study Drug Discontinuation | Drug-related AEs leading to discontinuation | 2 participants |
| All Treated Participants | Number of Participants Who Died, Serious Adverse Events (SAEs), Adverse Events (AEs) and AEs Leading to Study Drug Discontinuation | Deaths within 30 days of last dose | 1 participants |
| All Treated Participants | Number of Participants Who Died, Serious Adverse Events (SAEs), Adverse Events (AEs) and AEs Leading to Study Drug Discontinuation | AEs leading to discontinuation | 2 participants |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants Who Died, Serious Adverse Events (SAEs), Adverse Events (AEs) and AEs Leading to Study Drug Discontinuation | Deaths within 30 days of last dose | 1 participants |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants Who Died, Serious Adverse Events (SAEs), Adverse Events (AEs) and AEs Leading to Study Drug Discontinuation | Drug-related SAEs | 1 participants |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants Who Died, Serious Adverse Events (SAEs), Adverse Events (AEs) and AEs Leading to Study Drug Discontinuation | All deaths | 2 participants |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants Who Died, Serious Adverse Events (SAEs), Adverse Events (AEs) and AEs Leading to Study Drug Discontinuation | All SAEs | 2 participants |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants Who Died, Serious Adverse Events (SAEs), Adverse Events (AEs) and AEs Leading to Study Drug Discontinuation | AEs leading to discontinuation | 1 participants |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants Who Died, Serious Adverse Events (SAEs), Adverse Events (AEs) and AEs Leading to Study Drug Discontinuation | Drug-related AEs | 3 participants |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants Who Died, Serious Adverse Events (SAEs), Adverse Events (AEs) and AEs Leading to Study Drug Discontinuation | All AEs | 3 participants |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants Who Died, Serious Adverse Events (SAEs), Adverse Events (AEs) and AEs Leading to Study Drug Discontinuation | Drug-related AEs leading to discontinuation | 0 participants |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants Who Died, Serious Adverse Events (SAEs), Adverse Events (AEs) and AEs Leading to Study Drug Discontinuation | All SAEs | 2 participants |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants Who Died, Serious Adverse Events (SAEs), Adverse Events (AEs) and AEs Leading to Study Drug Discontinuation | All AEs | 3 participants |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants Who Died, Serious Adverse Events (SAEs), Adverse Events (AEs) and AEs Leading to Study Drug Discontinuation | Drug-related AEs | 3 participants |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants Who Died, Serious Adverse Events (SAEs), Adverse Events (AEs) and AEs Leading to Study Drug Discontinuation | All deaths | 0 participants |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants Who Died, Serious Adverse Events (SAEs), Adverse Events (AEs) and AEs Leading to Study Drug Discontinuation | Deaths within 30 days of last dose | 0 participants |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants Who Died, Serious Adverse Events (SAEs), Adverse Events (AEs) and AEs Leading to Study Drug Discontinuation | Drug-related SAEs | 1 participants |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants Who Died, Serious Adverse Events (SAEs), Adverse Events (AEs) and AEs Leading to Study Drug Discontinuation | AEs leading to discontinuation | 1 participants |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants Who Died, Serious Adverse Events (SAEs), Adverse Events (AEs) and AEs Leading to Study Drug Discontinuation | Drug-related AEs leading to discontinuation | 0 participants |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants Who Died, Serious Adverse Events (SAEs), Adverse Events (AEs) and AEs Leading to Study Drug Discontinuation | Drug-related SAEs | 1 participants |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants Who Died, Serious Adverse Events (SAEs), Adverse Events (AEs) and AEs Leading to Study Drug Discontinuation | All deaths | 1 participants |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants Who Died, Serious Adverse Events (SAEs), Adverse Events (AEs) and AEs Leading to Study Drug Discontinuation | Drug-related AEs | 6 participants |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants Who Died, Serious Adverse Events (SAEs), Adverse Events (AEs) and AEs Leading to Study Drug Discontinuation | All AEs | 6 participants |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants Who Died, Serious Adverse Events (SAEs), Adverse Events (AEs) and AEs Leading to Study Drug Discontinuation | Drug-related AEs leading to discontinuation | 0 participants |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants Who Died, Serious Adverse Events (SAEs), Adverse Events (AEs) and AEs Leading to Study Drug Discontinuation | All SAEs | 5 participants |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants Who Died, Serious Adverse Events (SAEs), Adverse Events (AEs) and AEs Leading to Study Drug Discontinuation | Deaths within 30 days of last dose | 0 participants |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants Who Died, Serious Adverse Events (SAEs), Adverse Events (AEs) and AEs Leading to Study Drug Discontinuation | AEs leading to discontinuation | 1 participants |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants Who Died, Serious Adverse Events (SAEs), Adverse Events (AEs) and AEs Leading to Study Drug Discontinuation | Drug-related AEs | 17 participants |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants Who Died, Serious Adverse Events (SAEs), Adverse Events (AEs) and AEs Leading to Study Drug Discontinuation | Drug-related AEs leading to discontinuation | 7 participants |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants Who Died, Serious Adverse Events (SAEs), Adverse Events (AEs) and AEs Leading to Study Drug Discontinuation | Drug-related SAEs | 4 participants |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants Who Died, Serious Adverse Events (SAEs), Adverse Events (AEs) and AEs Leading to Study Drug Discontinuation | All deaths | 3 participants |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants Who Died, Serious Adverse Events (SAEs), Adverse Events (AEs) and AEs Leading to Study Drug Discontinuation | All AEs | 17 participants |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants Who Died, Serious Adverse Events (SAEs), Adverse Events (AEs) and AEs Leading to Study Drug Discontinuation | AEs leading to discontinuation | 8 participants |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants Who Died, Serious Adverse Events (SAEs), Adverse Events (AEs) and AEs Leading to Study Drug Discontinuation | All SAEs | 9 participants |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants Who Died, Serious Adverse Events (SAEs), Adverse Events (AEs) and AEs Leading to Study Drug Discontinuation | Deaths within 30 days of last dose | 2 participants |
Primary
Number of Participants With Dose-limiting Toxicity (DLT)
DLTs: At least possibly drug-related AEs occurring during the first cycle of treatment and are:GR4 neutropenia \>5 days/neutropenic fever;platelet count \<10000mm\^3 on \>1 occasion;GR4 fatigue,or 2-point decline in ECOG performance status;\>=GR3 nausea,diarrhea,and vomiting despite medical intervention;Any other clinically significant non-hematologic toxicity of \>=GR3 considered not related to underlying MM;Any GR3/4 laboratory abnormality requiring hospitalization;dose interruption of either dasatinib and/or lenalidomide for \>15 days due to any toxicity related to treatment with the combination.
Time frame: From the date of first dose until at least 30 days after the last dose of study drug (median duration of dasatinib treatment=5.2 months [range 0 to 33 months]).
Population: All treated participants, participants who received at least 1 dose of dasatinib. (Participants included from Cohort 5 are those involved in the dose escalation phase only.)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Treated Participants | Number of Participants With Dose-limiting Toxicity (DLT) | 1 participants |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Dose-limiting Toxicity (DLT) | 0 participants |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Dose-limiting Toxicity (DLT) | 0 participants |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Dose-limiting Toxicity (DLT) | 1 participants |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Dose-limiting Toxicity (DLT) | 0 participants |
Primary
Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia
As per NCI CTCAE Version 3.0 criteria. Grade (GR)1=Mild; GR2=Moderate; GR3=Severe; GR4=Life-threatening or disabling. White blood cell (WBC):GR1=\<LLN(lower limit of normal)-3.0\*10\^9/L; GR2=\<3.0-2.0\*10\^9/L; GR3:\<2.0-1.0\*10\^9/L; GR4:\<1.0\*10\^9/L. LLN=lower limit of normal. Absolute Neutrophil Count (ANC): GR1=\<LLN-1.5\*10\^9/L; GR2=\<1.5-1.0\*10\^9/L; GR3:\<1.0-0.5\*10\^9/L; GR4:\<0.5\*10\^9/L. Hemoglobin: GR1=\<LLN-10.0g/dL; GR2=\<10.0-8.0g/dL; GR3:\<8.0-6.5g/dL; GR4:\<6.5g/dL. Platelets: GR1=\<LLN-75.0\*10\^9/L; GR2=\<75.0-50.0\*10\^9/L; GR3:\<50.0-25.0\*10\^9/L; GR4:\<25.0\*10\^9/L. BL=Baseline; PBL=post baseline.
Time frame: Baseline (pretreatment); Cycles 1 and 2 (within 24 hours of Days 1, 4, 8, 11, 15, 18, 21, and 25); beyond Cycle 2 (within 24 hours of Days 1 and 15,off treatment visit ) (median duration of dasatinib treatment=5.2 mo [range 0 to 33 mo])
Population: All treated participants, participants who received at least 1 dose of dasatinib.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Treated Participants | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Neutropenia; GR 1 to 2 at BL, GR 3 to 4 PBL | 1 participants |
| All Treated Participants | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Thrombocytopenia; GR 1 to 2 at BL, GR 3 to 4 PBL | 2 participants |
| All Treated Participants | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Thrombocytopenia; GR 0 at BL, GR 0 PBL | 0 participants |
| All Treated Participants | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Thrombocytopenia; GR 1 to 2 at BL, GR 1 to 2 PBL | 1 participants |
| All Treated Participants | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Thrombocytopenia; GR 0 at BL, GR 1 to 2 PBL | 3 participants |
| All Treated Participants | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Anemia; GR 3 to 4 at BL, GR 1 to 2 PBL | 0 participants |
| All Treated Participants | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Thrombocytopenia; GR 1 to 2 at BL, GR 0 PBL | 0 participants |
| All Treated Participants | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Thrombocytopenia; GR 0 at BL, GR 3 to 4 PBL | 0 participants |
| All Treated Participants | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Leukopenia; GR 1 to 2 at BL, GR 0 PBL | 0 participants |
| All Treated Participants | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Anemia; GR Not reported at BL | 0 participants |
| All Treated Participants | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Leukopenia; GR 0 at BL, GR 0 PBL | 0 participants |
| All Treated Participants | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Leukopenia; GR 1 to 2 at BL, GR 1 to 2 PBL | 0 participants |
| All Treated Participants | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Leukopenia; GR 0 at BL, GR 1 to 2 PBL | 1 participants |
| All Treated Participants | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Anemia; GR 3 to 4 at BL, GR 0 PBL | 0 participants |
| All Treated Participants | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Leukopenia; GR 1 to 2 at BL, GR 3 to 4 PBL | 3 participants |
| All Treated Participants | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Anemia; GR 1 to 2 at BL, GR 3 to 4 PBL | 1 participants |
| All Treated Participants | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Neutropenia; GR 0 at BL, GR 0 PBL | 0 participants |
| All Treated Participants | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Anemia; GR 1 to 2 at BL, GR 1 to 2 PBL | 4 participants |
| All Treated Participants | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Neutropenia; GR 0 at BL, GR 1 to 2 PBL | 2 participants |
| All Treated Participants | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Anemia; GR 1 to 2 at BL, GR 0 PBL | 0 participants |
| All Treated Participants | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Neutropenia; GR 0 at BL, GR 3 to 4 PBL | 3 participants |
| All Treated Participants | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Anemia; GR 3 to 4 at BL, GR 3 to 4 PBL | 1 participants |
| All Treated Participants | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Anemia; GR 0 at BL, GR 3 to 4 PBL | 0 participants |
| All Treated Participants | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Neutropenia; GR 1 to 2 at BL, GR 0 | 0 participants |
| All Treated Participants | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Leukopenia; GR 0 at BL, GR 3 to 4 PBL | 2 participants |
| All Treated Participants | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Anemia; GR 0 at BL, GR 1 to 2 PBL | 0 participants |
| All Treated Participants | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Neutropenia; GR 1 to 2 at BL, GR 1 to 2 PBL | 0 participants |
| All Treated Participants | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Anemia; GR 0 at BL, GR 0 PBL | 0 participants |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Thrombocytopenia; GR 1 to 2 at BL, GR 3 to 4 PBL | 1 participants |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Anemia; GR Not reported at BL | 0 participants |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Anemia; GR 1 to 2 at BL, GR 1 to 2 PBL | 1 participants |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Thrombocytopenia; GR 1 to 2 at BL, GR 1 to 2 PBL | 0 participants |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Anemia; GR 0 at BL, GR 1 to 2 PBL | 1 participants |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Thrombocytopenia; GR 0 at BL, GR 0 PBL | 1 participants |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Anemia; GR 3 to 4 at BL, GR 1 to 2 PBL | 0 participants |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Neutropenia; GR 0 at BL, GR 0 PBL | 1 participants |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Thrombocytopenia; GR 1 to 2 at BL, GR 0 PBL | 0 participants |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Leukopenia; GR 0 at BL, GR 0 PBL | 2 participants |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Thrombocytopenia; GR 0 at BL, GR 1 to 2 PBL | 1 participants |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Neutropenia; GR 1 to 2 at BL, GR 1 to 2 PBL | 0 participants |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Anemia; GR 1 to 2 at BL, GR 0 PBL | 0 participants |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Thrombocytopenia; GR 0 at BL, GR 3 to 4 PBL | 0 participants |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Neutropenia; GR 1 to 2 at BL, GR 0 | 0 participants |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Neutropenia; GR 0 at BL, GR 1 to 2 PBL | 1 participants |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Leukopenia; GR 1 to 2 at BL, GR 0 PBL | 0 participants |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Anemia; GR 3 to 4 at BL, GR 3 to 4 PBL | 0 participants |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Leukopenia; GR 0 at BL, GR 3 to 4 PBL | 0 participants |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Anemia; GR 3 to 4 at BL, GR 0 PBL | 0 participants |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Anemia; GR 0 at BL, GR 3 to 4 PBL | 0 participants |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Leukopenia; GR 1 to 2 at BL, GR 1 to 2 PBL | 0 participants |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Neutropenia; GR 1 to 2 at BL, GR 3 to 4 PBL | 0 participants |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Neutropenia; GR 0 at BL, GR 3 to 4 PBL | 1 participants |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Anemia; GR 1 to 2 at BL, GR 3 to 4 PBL | 1 participants |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Anemia; GR 0 at BL, GR 0 PBL | 0 participants |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Leukopenia; GR 1 to 2 at BL, GR 3 to 4 PBL | 0 participants |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Leukopenia; GR 0 at BL, GR 1 to 2 PBL | 1 participants |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Anemia; GR 3 to 4 at BL, GR 0 PBL | 0 participants |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Leukopenia; GR 0 at BL, GR 0 PBL | 0 participants |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Leukopenia; GR 0 at BL, GR 1 to 2 PBL | 3 participants |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Leukopenia; GR 0 at BL, GR 3 to 4 PBL | 0 participants |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Leukopenia; GR 1 to 2 at BL, GR 0 PBL | 0 participants |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Leukopenia; GR 1 to 2 at BL, GR 1 to 2 PBL | 0 participants |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Leukopenia; GR 1 to 2 at BL, GR 3 to 4 PBL | 0 participants |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Neutropenia; GR 0 at BL, GR 0 PBL | 0 participants |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Neutropenia; GR 0 at BL, GR 1 to 2 PBL | 2 participants |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Neutropenia; GR 0 at BL, GR 3 to 4 PBL | 1 participants |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Neutropenia; GR 1 to 2 at BL, GR 0 | 0 participants |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Neutropenia; GR 1 to 2 at BL, GR 1 to 2 PBL | 0 participants |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Neutropenia; GR 1 to 2 at BL, GR 3 to 4 PBL | 0 participants |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Thrombocytopenia; GR 0 at BL, GR 0 PBL | 0 participants |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Thrombocytopenia; GR 0 at BL, GR 1 to 2 PBL | 2 participants |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Thrombocytopenia; GR 0 at BL, GR 3 to 4 PBL | 0 participants |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Thrombocytopenia; GR 1 to 2 at BL, GR 0 PBL | 0 participants |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Thrombocytopenia; GR 1 to 2 at BL, GR 1 to 2 PBL | 1 participants |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Thrombocytopenia; GR 1 to 2 at BL, GR 3 to 4 PBL | 0 participants |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Anemia; GR 0 at BL, GR 0 PBL | 0 participants |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Anemia; GR 0 at BL, GR 1 to 2 PBL | 1 participants |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Anemia; GR 0 at BL, GR 3 to 4 PBL | 0 participants |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Anemia; GR 1 to 2 at BL, GR 0 PBL | 0 participants |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Anemia; GR 1 to 2 at BL, GR 1 to 2 PBL | 1 participants |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Anemia; GR 1 to 2 at BL, GR 3 to 4 PBL | 1 participants |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Anemia; GR 3 to 4 at BL, GR 1 to 2 PBL | 0 participants |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Anemia; GR 3 to 4 at BL, GR 3 to 4 PBL | 0 participants |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Anemia; GR Not reported at BL | 0 participants |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Anemia; GR 0 at BL, GR 1 to 2 PBL | 3 participants |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Anemia; GR 1 to 2 at BL, GR 1 to 2 PBL | 1 participants |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Thrombocytopenia; GR 1 to 2 at BL, GR 3 to 4 PBL | 1 participants |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Leukopenia; GR 1 to 2 at BL, GR 3 to 4 PBL | 3 participants |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Neutropenia; GR 0 at BL, GR 3 to 4 PBL | 0 participants |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Leukopenia; GR 0 at BL, GR 0 PBL | 1 participants |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Anemia; GR 1 to 2 at BL, GR 3 to 4 PBL | 1 participants |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Leukopenia; GR 0 at BL, GR 1 to 2 PBL | 2 participants |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Leukopenia; GR 1 to 2 at BL, GR 1 to 2 PBL | 0 participants |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Anemia; GR 3 to 4 at BL, GR 3 to 4 PBL | 0 participants |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Leukopenia; GR 1 to 2 at BL, GR 0 PBL | 0 participants |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Anemia; GR 3 to 4 at BL, GR 0 PBL | 0 participants |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Anemia; GR 0 at BL, GR 3 to 4 PBL | 0 participants |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Anemia; GR 0 at BL, GR 0 PBL | 0 participants |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Leukopenia; GR 0 at BL, GR 3 to 4 PBL | 0 participants |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Neutropenia; GR 0 at BL, GR 1 to 2 PBL | 3 participants |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Neutropenia; GR 1 to 2 at BL, GR 3 to 4 PBL | 3 participants |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Thrombocytopenia; GR 0 at BL, GR 3 to 4 PBL | 0 participants |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Neutropenia; GR 1 to 2 at BL, GR 0 | 0 participants |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Thrombocytopenia; GR 0 at BL, GR 1 to 2 PBL | 3 participants |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Anemia; GR 1 to 2 at BL, GR 0 PBL | 0 participants |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Anemia; GR 3 to 4 at BL, GR 1 to 2 PBL | 0 participants |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Thrombocytopenia; GR 1 to 2 at BL, GR 0 PBL | 0 participants |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Neutropenia; GR 1 to 2 at BL, GR 1 to 2 PBL | 0 participants |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Thrombocytopenia; GR 0 at BL, GR 0 PBL | 1 participants |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Neutropenia; GR 0 at BL, GR 0 PBL | 0 participants |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Anemia; GR Not reported at BL | 1 participants |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Thrombocytopenia; GR 1 to 2 at BL, GR 1 to 2 PBL | 1 participants |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Thrombocytopenia; GR 0 at BL, GR 0 PBL | 2 participants |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Neutropenia; GR 1 to 2 at BL, GR 1 to 2 PBL | 1 participants |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Leukopenia; GR 0 at BL, GR 1 to 2 PBL | 6 participants |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Thrombocytopenia; GR 1 to 2 at BL, GR 3 to 4 PBL | 5 participants |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Neutropenia; GR 1 to 2 at BL, GR 0 | 0 participants |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Anemia; GR 0 at BL, GR 0 PBL | 0 participants |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Neutropenia; GR 0 at BL, GR 3 to 4 PBL | 8 participants |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Anemia; GR 0 at BL, GR 1 to 2 PBL | 6 participants |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Neutropenia; GR 0 at BL, GR 1 to 2 PBL | 3 participants |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Anemia; GR 0 at BL, GR 3 to 4 PBL | 1 participants |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Neutropenia; GR 0 at BL, GR 0 PBL | 1 participants |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Anemia; GR 3 to 4 at BL, GR 3 to 4 PBL | 0 participants |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Anemia; GR 1 to 2 at BL, GR 0 PBL | 0 participants |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Leukopenia; GR 1 to 2 at BL, GR 3 to 4 PBL | 5 participants |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Leukopenia; GR 0 at BL, GR 0 PBL | 2 participants |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Anemia; GR 1 to 2 at BL, GR 1 to 2 PBL | 5 participants |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Leukopenia; GR 1 to 2 at BL, GR 1 to 2 PBL | 1 participants |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Anemia; GR 1 to 2 at BL, GR 3 to 4 PBL | 5 participants |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Leukopenia; GR 1 to 2 at BL, GR 0 PBL | 0 participants |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Anemia; GR 3 to 4 at BL, GR 0 PBL | 0 participants |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Leukopenia; GR 0 at BL, GR 3 to 4 PBL | 3 participants |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Thrombocytopenia; GR 0 at BL, GR 1 to 2 PBL | 5 participants |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Anemia; GR Not reported at BL | 0 participants |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Thrombocytopenia; GR 0 at BL, GR 3 to 4 PBL | 2 participants |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Thrombocytopenia; GR 1 to 2 at BL, GR 1 to 2 PBL | 3 participants |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Thrombocytopenia; GR 1 to 2 at BL, GR 0 PBL | 0 participants |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Neutropenia; GR 1 to 2 at BL, GR 3 to 4 PBL | 4 participants |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia | Anemia; GR 3 to 4 at BL, GR 1 to 2 PBL | 0 participants |
Primary
Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC)
Grading as per NCI CTCAE Version 3.0 criteria. GR1=Mild; GR2=Moderate; GR3=Severe; GR4=Life-threatening or disabling. Aspartate aminotransferase (AST) and alanine aminotransferase(ALT): GR1=\>ULN-2.5\*ULN (upper limit of normal); GR2=\>2.5-5.0\*ULN; GR3=\>5.0-20.0\*ULN; GR4:\>20.0\*ULN; TB:GR1=\>ULN-1.5\*ULN, GR2=\>1.5-3.0\*ULN, GR3=\>3-10\*ULN, GR4=\>10\*ULN; SC: GR1=\>ULN-1.5\*ULN, GR2=\>1.5-3.0\*ULN, GR3=\>3.0-6.0\*ULN, GR4=\>6.0\*ULN. BL=Baseline; PBL=post baseline.
Time frame: Baseline (pretreatment); Cycles 1 and 2 (within 24 hours of Days 1, 4, 8, 11, 15, 18, 21, and 25); beyond Cycle 2 (within 24 hours of Days 1 and 15,off treatment visit ) (median duration of dasatinib treatment=5.2 mo [range 0 to 33 mo])
Population: All treated participants, participants who received at least 1 dose of dasatinib.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Treated Participants | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC) | Total Bilirubin; GR 0 at BL, GR 3 to 4 PBL | 0 participants |
| All Treated Participants | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC) | SC; GR 1 to 2 at BL, GR 0 PBL | 0 participants |
| All Treated Participants | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC) | ALT; GR 0 at BL, GR 3 to 4 PBL | 0 participants |
| All Treated Participants | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC) | Total Bilirubin; GR 0 at BL, GR 0 PBL | 5 participants |
| All Treated Participants | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC) | AST; GR 1 to 2 at BL, GR 3 to 4 PBL | 0 participants |
| All Treated Participants | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC) | ALT; GR 1 to 2 at BL, GR 3 to 4 PBL | 0 participants |
| All Treated Participants | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC) | ALT; GR 0 at BL, GR 1 to 2 PBL | 4 participants |
| All Treated Participants | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC) | AST; GR 0 at BL, GR 1 to 2 PBL | 2 participants |
| All Treated Participants | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC) | SC; GR 1 to 2 at BL, GR 1 to 2 PBL | 0 participants |
| All Treated Participants | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC) | High ALT; GR 0 at BL, GR 0 PBL | 2 participants |
| All Treated Participants | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC) | SC; GR 1 to 2 at BL, GR 3 to 4 PBL | 0 participants |
| All Treated Participants | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC) | SC; GR 0 at BL, GR 1 to 2 PBL | 2 participants |
| All Treated Participants | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC) | SC; GR 0 at BL, GR 0 PBL | 4 participants |
| All Treated Participants | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC) | SC; GR 0 at BL, GR 3 to 4 PBL | 0 participants |
| All Treated Participants | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC) | AST; GR 0 at BL, GR 3 to 4 PBL | 0 participants |
| All Treated Participants | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC) | AST; GR 1 to 2 at BL, GR 0 PBL | 0 participants |
| All Treated Participants | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC) | AST; GR 0 at BL, GR 0 PBL | 4 participants |
| All Treated Participants | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC) | ALT; GR 1 to 2 at BL, GR 1 to 2 PBL | 0 participants |
| All Treated Participants | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC) | Total Bilirubin; GR 0 at BL, GR 1 to 2 PBL | 1 participants |
| All Treated Participants | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC) | ALT; GR 1 to 2 at BL, GR 0 PBL | 0 participants |
| All Treated Participants | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC) | AST; GR 1 to 2 at BL, GR 1 to 2 PBL | 0 participants |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC) | SC; GR 1 to 2 at BL, GR 3 to 4 PBL | 0 participants |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC) | Total Bilirubin; GR 0 at BL, GR 1 to 2 PBL | 1 participants |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC) | SC; GR 0 at BL, GR 1 to 2 PBL | 1 participants |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC) | Total Bilirubin; GR 0 at BL, GR 3 to 4 PBL | 0 participants |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC) | SC; GR 0 at BL, GR 0 PBL | 1 participants |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC) | AST; GR 1 to 2 at BL, GR 0 PBL | 0 participants |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC) | AST; GR 0 at BL, GR 0 PBL | 0 participants |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC) | AST; GR 1 to 2 at BL, GR 1 to 2 PBL | 1 participants |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC) | SC; GR 1 to 2 at BL, GR 1 to 2 PBL | 1 participants |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC) | AST; GR 1 to 2 at BL, GR 3 to 4 PBL | 0 participants |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC) | High ALT; GR 0 at BL, GR 0 PBL | 1 participants |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC) | AST; GR 0 at BL, GR 1 to 2 PBL | 2 participants |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC) | ALT; GR 0 at BL, GR 1 to 2 PBL | 0 participants |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC) | SC; GR 1 to 2 at BL, GR 0 PBL | 0 participants |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC) | ALT; GR 0 at BL, GR 3 to 4 PBL | 1 participants |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC) | ALT; GR 1 to 2 at BL, GR 0 PBL | 0 participants |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC) | ALT; GR 1 to 2 at BL, GR 1 to 2 PBL | 1 participants |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC) | SC; GR 0 at BL, GR 3 to 4 PBL | 0 participants |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC) | ALT; GR 1 to 2 at BL, GR 3 to 4 PBL | 0 participants |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC) | AST; GR 0 at BL, GR 3 to 4 PBL | 0 participants |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC) | Total Bilirubin; GR 0 at BL, GR 0 PBL | 1 participants |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC) | ALT; GR 0 at BL, GR 3 to 4 PBL | 1 participants |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC) | SC; GR 1 to 2 at BL, GR 3 to 4 PBL | 0 participants |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC) | AST; GR 1 to 2 at BL, GR 1 to 2 PBL | 1 participants |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC) | SC; GR 1 to 2 at BL, GR 1 to 2 PBL | 0 participants |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC) | ALT; GR 1 to 2 at BL, GR 3 to 4 PBL | 0 participants |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC) | ALT; GR 1 to 2 at BL, GR 0 PBL | 0 participants |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC) | AST; GR 0 at BL, GR 3 to 4 PBL | 0 participants |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC) | SC; GR 0 at BL, GR 3 to 4 PBL | 0 participants |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC) | AST; GR 1 to 2 at BL, GR 0 PBL | 0 participants |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC) | Total Bilirubin; GR 0 at BL, GR 0 PBL | 2 participants |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC) | ALT; GR 1 to 2 at BL, GR 1 to 2 PBL | 1 participants |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC) | High ALT; GR 0 at BL, GR 0 PBL | 1 participants |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC) | SC; GR 0 at BL, GR 0 PBL | 1 participants |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC) | SC; GR 1 to 2 at BL, GR 0 PBL | 0 participants |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC) | AST; GR 1 to 2 at BL, GR 3 to 4 PBL | 0 participants |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC) | Total Bilirubin; GR 0 at BL, GR 1 to 2 PBL | 1 participants |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC) | ALT; GR 0 at BL, GR 1 to 2 PBL | 0 participants |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC) | AST; GR 0 at BL, GR 1 to 2 PBL | 0 participants |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC) | Total Bilirubin; GR 0 at BL, GR 3 to 4 PBL | 0 participants |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC) | AST; GR 0 at BL, GR 0 PBL | 2 participants |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC) | SC; GR 0 at BL, GR 1 to 2 PBL | 2 participants |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC) | SC; GR 0 at BL, GR 0 PBL | 6 participants |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC) | AST; GR 0 at BL, GR 1 to 2 PBL | 0 participants |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC) | AST; GR 0 at BL, GR 3 to 4 PBL | 0 participants |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC) | AST; GR 1 to 2 at BL, GR 0 PBL | 0 participants |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC) | AST; GR 1 to 2 at BL, GR 1 to 2 PBL | 1 participants |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC) | AST; GR 1 to 2 at BL, GR 3 to 4 PBL | 0 participants |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC) | High ALT; GR 0 at BL, GR 0 PBL | 2 participants |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC) | ALT; GR 0 at BL, GR 1 to 2 PBL | 3 participants |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC) | ALT; GR 0 at BL, GR 3 to 4 PBL | 0 participants |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC) | ALT; GR 1 to 2 at BL, GR 0 PBL | 0 participants |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC) | ALT; GR 1 to 2 at BL, GR 1 to 2 PBL | 1 participants |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC) | ALT; GR 1 to 2 at BL, GR 3 to 4 PBL | 0 participants |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC) | Total Bilirubin; GR 0 at BL, GR 0 PBL | 4 participants |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC) | Total Bilirubin; GR 0 at BL, GR 1 to 2 PBL | 2 participants |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC) | Total Bilirubin; GR 0 at BL, GR 3 to 4 PBL | 0 participants |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC) | AST; GR 0 at BL, GR 0 PBL | 5 participants |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC) | SC; GR 0 at BL, GR 1 to 2 PBL | 0 participants |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC) | SC; GR 0 at BL, GR 3 to 4 PBL | 0 participants |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC) | SC; GR 1 to 2 at BL, GR 0 PBL | 0 participants |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC) | SC; GR 1 to 2 at BL, GR 1 to 2 PBL | 0 participants |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC) | SC; GR 1 to 2 at BL, GR 3 to 4 PBL | 0 participants |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC) | SC; GR 0 at BL, GR 1 to 2 PBL | 3 participants |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC) | ALT; GR 1 to 2 at BL, GR 3 to 4 PBL | 1 participants |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC) | ALT; GR 1 to 2 at BL, GR 1 to 2 PBL | 2 participants |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC) | ALT; GR 1 to 2 at BL, GR 0 PBL | 0 participants |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC) | AST; GR 0 at BL, GR 1 to 2 PBL | 8 participants |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC) | SC; GR 0 at BL, GR 3 to 4 PBL | 1 participants |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC) | ALT; GR 0 at BL, GR 3 to 4 PBL | 0 participants |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC) | ALT; GR 0 at BL, GR 1 to 2 PBL | 9 participants |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC) | High ALT; GR 0 at BL, GR 0 PBL | 5 participants |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC) | AST; GR 0 at BL, GR 0 PBL | 5 participants |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC) | SC; GR 1 to 2 at BL, GR 0 PBL | 0 participants |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC) | AST; GR 1 to 2 at BL, GR 3 to 4 PBL | 1 participants |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC) | AST; GR 1 to 2 at BL, GR 1 to 2 PBL | 3 participants |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC) | AST; GR 1 to 2 at BL, GR 0 PBL | 0 participants |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC) | SC; GR 1 to 2 at BL, GR 3 to 4 PBL | 1 participants |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC) | SC; GR 1 to 2 at BL, GR 1 to 2 PBL | 0 participants |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC) | SC; GR 0 at BL, GR 0 PBL | 12 participants |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC) | Total Bilirubin; GR 0 at BL, GR 3 to 4 PBL | 0 participants |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC) | Total Bilirubin; GR 0 at BL, GR 1 to 2 PBL | 4 participants |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC) | Total Bilirubin; GR 0 at BL, GR 0 PBL | 13 participants |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC) | AST; GR 0 at BL, GR 3 to 4 PBL | 0 participants |
Primary
Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus
Grading as per NCI CTCAE Version 3.0 criteria. GR1=Mild; GR2=Moderate; GR3=Severe; GR4=Life-threatening or disabling. Calcium (low): GR1: \<LLN - 8.0 mg/dL, GR2: \<8.0 - 7.0 mg/dL, GR3: \<7.0 - 6.0 mg/dL, GR4: \<6.0 mg/dL. Calcium (High): GR1: \>ULN - 11.5 mg/dL, GR2: \>11.5 - 12.5 mg/dL, GR3: \>12.5 - 13.5 mg/dL, GR4: \>13.5 mg/dL. Magnesium (Low): GR1: \<LLN - 1.2 mg/dL, GR2: \<1.2 - 0.9 mg/dL, GR3: \<0.9 - 0.7 mg/dL, GR4: \<0.7 mg/dL. Phosphorus (low): GR1: \<LLN - 2.5 mg/dL, GR2: \<2.5 - 2.0 mg/dL, GR3: \<2.0 - 1.0 mg/dL, GR4: \<1.0 mg/dL. BL=Baseline; PBL=post baseline.
Time frame: Baseline (pretreatment); Cycles 1 and 2 (within 24 hours of Days 1, 4, 8, 11, 15, 18, 21, and 25); beyond Cycle 2 (within 24 hours of Days 1 and 15,off treatment visit ) (median duration of dasatinib treatment=5.2 mo [range 0 to 33 mo])
Population: All treated participants, participants who received at least 1 dose of dasatinib.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Treated Participants | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Low Magnesium; GR Not reported at BL | 0 participants |
| All Treated Participants | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Low Calcium; GR 1 to 2 at BL, GR 3 to 4 PBL | 0 participants |
| All Treated Participants | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Low Phosphorus; GR 3 to 4 at BL, GR 1 to 2 PBL | 0 participants |
| All Treated Participants | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Low Magnesium; GR 1 to 2 at BL, GR 1 to 2 PBL | 1 participants |
| All Treated Participants | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Low Magnesium; GR 0 at BL, GR 0 PBL | 2 participants |
| All Treated Participants | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | High Calcium; GR 0 at BL, GR 3 to 4 PBL | 0 participants |
| All Treated Participants | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Low Magnesium; GR 1 to 2 at BL, GR 0 PBL | 0 participants |
| All Treated Participants | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Low Magnesium; GR 0 at BL, GR 1 to 2 PBL | 3 participants |
| All Treated Participants | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Low Magnesium; GR 0 at BL, GR 3 to 4 PBL | 0 participants |
| All Treated Participants | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Low Phosphorus; GR 3 to 4 at BL, GR 0 PBL | 0 participants |
| All Treated Participants | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | High Calcium; GR 1 to 2 at BL, GR 0 PBL | 0 participants |
| All Treated Participants | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | High Calcium; GR 0 at BL, GR 0PBL | 4 participants |
| All Treated Participants | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | High Calcium; GR 1 to 2 at BL, GR 1 to 2 PBL | 0 participants |
| All Treated Participants | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Low Magnesium; GR 1 to 2 at BL, GR 3 to 4 PBL | 0 participants |
| All Treated Participants | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Low Phosphorus; GR 1 to 2 at BL, GR 3 to 4 PBL | 0 participants |
| All Treated Participants | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | High Calcium; GR 1 to 2 at BL, GR 3 to 4 PBL | 1 participants |
| All Treated Participants | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Low Phosphorus; GR 1 to 2 at BL, GR 1 to 2 PBL | 0 participants |
| All Treated Participants | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Low Calcium; GR 0 at BL, GR 0 PBL | 2 participants |
| All Treated Participants | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Low Phosphorus; GR 3 to 4 at BL, GR 3 to 4 PBL | 0 participants |
| All Treated Participants | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Low Phosphorus; GR 1 to 2 at BL, GR 0 PBL | 0 participants |
| All Treated Participants | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Low Calcium; GR 0 at BL, GR 1 to 2 PBL | 3 participants |
| All Treated Participants | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | High Calcium; GR 0 at BL, GR 1 to 2 PBL | 1 participants |
| All Treated Participants | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Low Phosphorus; GR 0 at BL, GR 3 to 4 PBL | 1 participants |
| All Treated Participants | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Low Calcium; GR 0 at BL, GR 3 to 4 PBL | 0 participants |
| All Treated Participants | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Low Phosphorus; GR 0 at BL, GR 1 to 2 PBL | 3 participants |
| All Treated Participants | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Low Calcium; GR 1 to 2 at BL, GR 0 PBL | 0 participants |
| All Treated Participants | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Low Phosphorus; GR 0 at BL, GR 0 PBL | 1 participants |
| All Treated Participants | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Low Calcium; GR 1 to 2 at BL, GR 1 to 2 PBL | 1 participants |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Low Phosphorus; GR 1 to 2 at BL, GR 1 to 2 PBL | 0 participants |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Low Magnesium; GR 1 to 2 at BL, GR 1 to 2 PBL | 0 participants |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Low Calcium; GR 1 to 2 at BL, GR 1 to 2 PBL | 1 participants |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Low Calcium; GR 1 to 2 at BL, GR 3 to 4 PBL | 0 participants |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | High Calcium; GR 1 to 2 at BL, GR 3 to 4 PBL | 0 participants |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Low Phosphorus; GR 3 to 4 at BL, GR 3 to 4 PBL | 0 participants |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Low Magnesium; GR 1 to 2 at BL, GR 0 PBL | 0 participants |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Low Calcium; GR 0 at BL, GR 3 to 4 PBL | 0 participants |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Low Magnesium; GR 0 at BL, GR 0 PBL | 1 participants |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Low Phosphorus; GR 1 to 2 at BL, GR 0 PBL | 0 participants |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | High Calcium; GR 0 at BL, GR 1 to 2 PBL | 0 participants |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Low Magnesium; GR 0 at BL, GR 3 to 4 PBL | 0 participants |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Low Calcium; GR 0 at BL, GR 0 PBL | 0 participants |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Low Magnesium; GR 0 at BL, GR 1 to 2 PBL | 2 participants |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | High Calcium; GR 0 at BL, GR 3 to 4 PBL | 0 participants |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Low Magnesium; GR Not reported at BL | 0 participants |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Low Calcium; GR 0 at BL, GR 1 to 2 PBL | 2 participants |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Low Phosphorus; GR 3 to 4 at BL, GR 0 PBL | 0 participants |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Low Phosphorus; GR 0 at BL, GR 0 PBL | 0 participants |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Low Phosphorus; GR 0 at BL, GR 3 to 4 PBL | 0 participants |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | High Calcium; GR 1 to 2 at BL, GR 0 PBL | 0 participants |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | High Calcium; GR 0 at BL, GR 0PBL | 2 participants |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Low Phosphorus; GR 3 to 4 at BL, GR 1 to 2 PBL | 0 participants |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Low Phosphorus; GR 1 to 2 at BL, GR 3 to 4 PBL | 0 participants |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Low Calcium; GR 1 to 2 at BL, GR 0 PBL | 0 participants |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | High Calcium; GR 1 to 2 at BL, GR 1 to 2 PBL | 1 participants |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Low Magnesium; GR 1 to 2 at BL, GR 3 to 4 PBL | 0 participants |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Low Phosphorus; GR 0 at BL, GR 1 to 2 PBL | 3 participants |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Low Phosphorus; GR 1 to 2 at BL, GR 3 to 4 PBL | 0 participants |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Low Magnesium; GR 1 to 2 at BL, GR 3 to 4 PBL | 0 participants |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | High Calcium; GR 0 at BL, GR 0PBL | 3 participants |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | High Calcium; GR 0 at BL, GR 1 to 2 PBL | 0 participants |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | High Calcium; GR 0 at BL, GR 3 to 4 PBL | 0 participants |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | High Calcium; GR 1 to 2 at BL, GR 0 PBL | 0 participants |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | High Calcium; GR 1 to 2 at BL, GR 1 to 2 PBL | 0 participants |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | High Calcium; GR 1 to 2 at BL, GR 3 to 4 PBL | 0 participants |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Low Calcium; GR 0 at BL, GR 0 PBL | 1 participants |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Low Calcium; GR 0 at BL, GR 1 to 2 PBL | 2 participants |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Low Calcium; GR 0 at BL, GR 3 to 4 PBL | 0 participants |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Low Calcium; GR 1 to 2 at BL, GR 0 PBL | 0 participants |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Low Calcium; GR 1 to 2 at BL, GR 1 to 2 PBL | 0 participants |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Low Calcium; GR 1 to 2 at BL, GR 3 to 4 PBL | 0 participants |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Low Magnesium; GR 0 at BL, GR 0 PBL | 3 participants |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Low Magnesium; GR 0 at BL, GR 1 to 2 PBL | 0 participants |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Low Magnesium; GR 0 at BL, GR 3 to 4 PBL | 0 participants |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Low Magnesium; GR 1 to 2 at BL, GR 0 PBL | 0 participants |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Low Magnesium; GR 1 to 2 at BL, GR 1 to 2 PBL | 0 participants |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Low Magnesium; GR Not reported at BL | 0 participants |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Low Phosphorus; GR 0 at BL, GR 0 PBL | 2 participants |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Low Phosphorus; GR 0 at BL, GR 1 to 2 PBL | 0 participants |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Low Phosphorus; GR 0 at BL, GR 3 to 4 PBL | 0 participants |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Low Phosphorus; GR 1 to 2 at BL, GR 0 PBL | 0 participants |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Low Phosphorus; GR 1 to 2 at BL, GR 1 to 2 PBL | 0 participants |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Low Phosphorus; GR 3 to 4 at BL, GR 0 PBL | 0 participants |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Low Phosphorus; GR 3 to 4 at BL, GR 1 to 2 PBL | 0 participants |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Low Phosphorus; GR 3 to 4 at BL, GR 3 to 4 PBL | 1 participants |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Low Phosphorus; GR 0 at BL, GR 0 PBL | 3 participants |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Low Phosphorus; GR 1 to 2 at BL, GR 0 PBL | 0 participants |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Low Magnesium; GR 1 to 2 at BL, GR 3 to 4 PBL | 0 participants |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | High Calcium; GR 1 to 2 at BL, GR 3 to 4 PBL | 0 participants |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Low Calcium; GR 0 at BL, GR 3 to 4 PBL | 0 participants |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | High Calcium; GR 0 at BL, GR 0PBL | 4 participants |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Low Phosphorus; GR 1 to 2 at BL, GR 1 to 2 PBL | 0 participants |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | High Calcium; GR 0 at BL, GR 1 to 2 PBL | 0 participants |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | High Calcium; GR 1 to 2 at BL, GR 1 to 2 PBL | 2 participants |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Low Phosphorus; GR 3 to 4 at BL, GR 1 to 2 PBL | 0 participants |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | High Calcium; GR 1 to 2 at BL, GR 0 PBL | 0 participants |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Low Phosphorus; GR 1 to 2 at BL, GR 3 to 4 PBL | 0 participants |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Low Phosphorus; GR 0 at BL, GR 1 to 2 PBL | 2 participants |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Low Magnesium; GR Not reported at BL | 0 participants |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | High Calcium; GR 0 at BL, GR 3 to 4 PBL | 0 participants |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Low Calcium; GR 0 at BL, GR 1 to 2 PBL | 4 participants |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Low Magnesium; GR 1 to 2 at BL, GR 1 to 2 PBL | 1 participants |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Low Magnesium; GR 0 at BL, GR 1 to 2 PBL | 3 participants |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Low Calcium; GR 1 to 2 at BL, GR 0 PBL | 0 participants |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Low Phosphorus; GR 3 to 4 at BL, GR 0 PBL | 0 participants |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Low Magnesium; GR 0 at BL, GR 3 to 4 PBL | 0 participants |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Low Phosphorus; GR 0 at BL, GR 3 to 4 PBL | 1 participants |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Low Magnesium; GR 0 at BL, GR 0 PBL | 2 participants |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Low Calcium; GR 1 to 2 at BL, GR 1 to 2 PBL | 0 participants |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Low Calcium; GR 0 at BL, GR 0 PBL | 2 participants |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Low Magnesium; GR 1 to 2 at BL, GR 0 PBL | 0 participants |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Low Phosphorus; GR 3 to 4 at BL, GR 3 to 4 PBL | 0 participants |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Low Calcium; GR 1 to 2 at BL, GR 3 to 4 PBL | 0 participants |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Low Phosphorus; GR 1 to 2 at BL, GR 1 to 2 PBL | 0 participants |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | High Calcium; GR 0 at BL, GR 1 to 2 PBL | 1 participants |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Low Magnesium; GR 1 to 2 at BL, GR 1 to 2 PBL | 3 participants |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Low Magnesium; GR 1 to 2 at BL, GR 3 to 4 PBL | 0 participants |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Low Calcium; GR 1 to 2 at BL, GR 0 PBL | 0 participants |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Low Magnesium; GR Not reported at BL | 0 participants |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Low Calcium; GR 0 at BL, GR 3 to 4 PBL | 2 participants |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Low Phosphorus; GR 0 at BL, GR 0 PBL | 8 participants |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Low Calcium; GR 0 at BL, GR 1 to 2 PBL | 12 participants |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Low Phosphorus; GR 0 at BL, GR 1 to 2 PBL | 2 participants |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Low Calcium; GR 0 at BL, GR 0 PBL | 1 participants |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Low Phosphorus; GR 3 to 4 at BL, GR 1 to 2 PBL | 0 participants |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Low Phosphorus; GR 0 at BL, GR 3 to 4 PBL | 6 participants |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | High Calcium; GR 1 to 2 at BL, GR 3 to 4 PBL | 0 participants |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | High Calcium; GR 0 at BL, GR 0PBL | 15 participants |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Low Phosphorus; GR 1 to 2 at BL, GR 0 PBL | 0 participants |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | High Calcium; GR 1 to 2 at BL, GR 1 to 2 PBL | 1 participants |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Low Calcium; GR 1 to 2 at BL, GR 1 to 2 PBL | 1 participants |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | High Calcium; GR 1 to 2 at BL, GR 0 PBL | 0 participants |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Low Phosphorus; GR 1 to 2 at BL, GR 3 to 4 PBL | 1 participants |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | High Calcium; GR 0 at BL, GR 3 to 4 PBL | 0 participants |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Low Phosphorus; GR 3 to 4 at BL, GR 3 to 4 PBL | 0 participants |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Low Magnesium; GR 0 at BL, GR 1 to 2 PBL | 6 participants |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Low Magnesium; GR 0 at BL, GR 0 PBL | 7 participants |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Low Magnesium; GR 0 at BL, GR 3 to 4 PBL | 1 participants |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Low Calcium; GR 1 to 2 at BL, GR 3 to 4 PBL | 1 participants |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Low Phosphorus; GR 3 to 4 at BL, GR 0 PBL | 0 participants |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus | Low Magnesium; GR 1 to 2 at BL, GR 0 PBL | 0 participants |
Primary
Recommended Phase II Dose (RP2D) of the Combination (Dasatinib + Lenalidomide + Dexamethasone)
The RP2D was based on the MTD which was defined as the maximum combined dose producing dose limiting toxicity (DLT) in \< 33% of participants treated at the individual dose levels in the combination. The MTD is considered the last dose level combination tested just below the maximum administered dose (MAD) level combination and for which DLTs were observed in less than or equal to 33% of participants during the escalation and expansion phase. If MTD was not reached Please refer to Outcome Measure 2 for the complete definition of DLT.
Time frame: From the date of first dose to end of treatment (median duration of dasatinib treatment=5.2 months [range 0 to 33 months]).
Population: All treated participants, participants who received at least 1 dose of dasatinib.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Treated Participants | Recommended Phase II Dose (RP2D) of the Combination (Dasatinib + Lenalidomide + Dexamethasone) | RP2D of dasatinib in the combination | 140 mg |
| All Treated Participants | Recommended Phase II Dose (RP2D) of the Combination (Dasatinib + Lenalidomide + Dexamethasone) | RP2D of lenalidomide in the combination | 25 mg |
| All Treated Participants | Recommended Phase II Dose (RP2D) of the Combination (Dasatinib + Lenalidomide + Dexamethasone) | RP2D dexamethasone in the combination | 40 mg |
Secondary
Number of Participants With Complete Response and Very Good Partial Response
Response criteria were based on The International Uniform Response Criteria for Multiple Myeloma (with a slight modification). Complete response was achieved when there was negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow. Very good partial response was achieved when serum and urine M-component was detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-component plus urine M-component \< 100 mg per 24 hour.
Time frame: Baseline, At the end of the treatment period (median duration of dasatinib treatment=5.2 months [range 0 to 33 months]).
Population: All treated participants, participants who received at least 1 dose of dasatinib.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Treated Participants | Number of Participants With Complete Response and Very Good Partial Response | Not reported | 1 participants |
| All Treated Participants | Number of Participants With Complete Response and Very Good Partial Response | No response | 4 participants |
| All Treated Participants | Number of Participants With Complete Response and Very Good Partial Response | Very good partial response | 0 participants |
| All Treated Participants | Number of Participants With Complete Response and Very Good Partial Response | Complete response | 0 participants |
| All Treated Participants | Number of Participants With Complete Response and Very Good Partial Response | Response Undetermined | 0 participants |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Complete Response and Very Good Partial Response | Response Undetermined | 0 participants |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Complete Response and Very Good Partial Response | Not reported | 0 participants |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Complete Response and Very Good Partial Response | Complete response | 0 participants |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Complete Response and Very Good Partial Response | Very good partial response | 0 participants |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Complete Response and Very Good Partial Response | No response | 2 participants |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Complete Response and Very Good Partial Response | Very good partial response | 0 participants |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Complete Response and Very Good Partial Response | Not reported | 0 participants |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Complete Response and Very Good Partial Response | Response Undetermined | 0 participants |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Complete Response and Very Good Partial Response | Complete response | 0 participants |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Complete Response and Very Good Partial Response | No response | 1 participants |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Complete Response and Very Good Partial Response | Complete response | 0 participants |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Complete Response and Very Good Partial Response | No response | 1 participants |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Complete Response and Very Good Partial Response | Very good partial response | 1 participants |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Complete Response and Very Good Partial Response | Not reported | 0 participants |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Complete Response and Very Good Partial Response | Response Undetermined | 0 participants |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Complete Response and Very Good Partial Response | Not reported | 0 participants |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Complete Response and Very Good Partial Response | Response Undetermined | 0 participants |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Complete Response and Very Good Partial Response | Complete response | 0 participants |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Complete Response and Very Good Partial Response | No response | 11 participants |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Complete Response and Very Good Partial Response | Very good partial response | 3 participants |
Secondary
Number of Participants With Minimal Response
Response criteria was based on The International Uniform Response Criteria for Multiple Myeloma (with a slight modification). Minimal Response was achieved when there was 25% to 49% reduction of serum M-Protein, 50% to 89% reduction in 24 hour urinary M-protein which still exceeded 200 mg/24 hour. If the serum and urine M-protein were unmeasurable, 25% to 49% reduction in plasma cells was required. In addition, if present at baseline, a 25% to 49% reduction in the size of soft tissue plasmacytomas was also required.
Time frame: Baseline, at the end of the treatment period (median duration of dasatinib treatment=5.2 months [range 0 to 33 months]).
Population: All treated participants, participants who received at least 1 dose of dasatinib.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Treated Participants | Number of Participants With Minimal Response | 0 participants |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Minimal Response | 0 participants |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Minimal Response | 0 participants |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Minimal Response | 0 participants |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Minimal Response | 0 participants |
Secondary
Number of Participants With Partial Response
Partial response was achieved when there was ≥50% reduction of serum M-protein (Mpr)and reduction in 24 hour urinary Mpr by ≥90% or to \<200 mg/24 hr. If the serum and urine Mpr were unmeasurable, a ≥50% decrease in the difference between involved and uninvolved free light chain (FLC) levels was required in place of the Mpr criteria. If serum, urine Mpr, and serum FLC assay were unmeasurable, ≥50% reduction in plasma cells was required in place of Mpr, provided baseline bone marrow plasma cell percentage was ≥30%; a ≥50% reduction in the size of soft tissue plasmacytomas was also required.
Time frame: Baseline, at the end of the treatment period (median duration of dasatinib treatment=5.2 months [range 0 to 33 months]).
Population: All treated participants, participants who received at least 1 dose of dasatinib.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Treated Participants | Number of Participants With Partial Response | 1 participants |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Partial Response | 1 participants |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | Number of Participants With Partial Response | 2 participants |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Partial Response | 4 participants |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | Number of Participants With Partial Response | 3 participants |